Director Of Regulatory Affairs

Glanbia PLC Chicago , IL 60602

Posted 4 months ago

Director of Regulatory and Scientific Affairs

Reports To: Vice President, Quality and Food Safety

Department: Quality Assurance

Location: Chicago or California

At Glanbia Nutritionals Inc., our portfolio centers around dairy and non-dairy nutritional ingredients. We co-innovate and deliver ingredient solutions and precision premixes for use in the mainstream food and beverage, infant and clinical, and functional nutrition markets. We are the number one provider of whey-based nutritional ingredients globally and the number one producer of American-style cheddar cheese. Our protein systems have transformed the bar and beverage categories bringing increased levels of protein, cleaner labels and greater product functionality to market. We have a direct presence in 21 countries, with manufacturing facilities in the US, Germany and China, and international sales and technical offices around the world.

Job Summary

The Senior Director of Regulatory and Scientific Affairs is responsible for formulating the worldwide proactive strategy for assuring regulatory compliance across the business related to existing commercial activity and emerging business opportunities. The position directs the implementation of regulatory review processes, strategy and programs within project teams for assigned products working vertically and horizontally within the Global Glanbia Nutritionals Organization. The position must interact successfully with all levels of management, directing, planning, reviewing, and contributing to the regulatory strategies and to provide expert regulatory direction, advisory and support. A key role will be to lead, direct and serve as SME on project teams, and within the manufacturing facilities, business development, and Sales Management to plan, prepare, review regulatory documentation to ensure compliance to National and International requirements such as USDA, FDA, China GB, EU Directives, FSMA, and other applicable regulations within a global environment. The role will serve as the primary reference point and 'go to' source for regulatory guidance across GN. This role will also work closely with the Regulatory leaders across Glanbia Plc to ensure consistency in regulatory and scientific approach across Group.

Essential Functions and Responsibilities (not restrictive)

  • Plan, prepare, and review regulatory documentation and ensure data and conclusions are suitable for submission to regulatory agencies. For complex critical submissions, this will be done in close collaboration with the VP of Quality and Food Safety

  • Serves as regulatory representative to assigned project teams, providing regulatory guidance and support to project teams to ensure compliance with applicable regulations. Ensure NPD Quality assurance by design & market regulatory compliance requirements

  • In association with the VP of Quality, be responsible for developing and implementing strategies for assigned programs

  • Work independently, directly, and effectively with functional disciplines to accomplish assigned day to day responsibilities

  • Support all applicable internal and external regulations, standards, policies and procedures related to the quality, food safety and regulatory status and performance of the group's operations, processes and products.

  • Work with GN management on scenario planning, risk simulation and protocols to product quality & food safety matters at group and GN level

  • Evaluate relevant US and Global regulations & guidelines for their impact on development activities & regulatory plans

  • Represent Glanbia Nutritionals at FDA and other regulatory agencies for all assigned products

  • Study scientific & legal documents and ensure compliance with all Regulations

  • Offering advice about Company polices, practices, and systems within the scope of Food Manufacturing environment

  • Liaising & negotiating with regulatory authorities, as well as serving as an able bodied spokesperson/ representative of Glanbia on regulatory and industry forums.

  • Provide compliance expertise and guidance, to maintain and/or gain required certifications across regions such as ISO, GFSI, NSF, Non-GMO, Organic, FDA, BRC, SQF, Kosher, Halal, etc. working towards common global standard(s) whenever possible

Supervisory Responsibilities (if applicable)

  • Plan and manage integration of multidisciplinary worldwide regulatory programs into the project management plans for all assigned projects from the discovery stage through commercialization. Working in a 'matrix'

reporting environment and with expert network development is required. 1-2 direct reports (US and Asia Pacific)

Performance indicators (related to above Task & Responsibilities respectively)

  • Culture of regulatory compliance & risk reduction across the organisation.

  • Number of Non-compliances with domestic / international regulations based on External / Internal Audits

  • Number of Non-compliances related to labelling

  • % of New products fully compliant with Quality standards

  • Number of internal standards, policies & procedures implemented

  • Number of regulatory non-compliance mitigations implemented

Qualification & Experience Requirements

Education, Training:

Bachelor's degree in a related scientific field (i.e. chemistry, biology, microbiology,g food science), master's or PhD preferred.

Experience Required:

  • Minimum of 10 years relevant experience in food manufacturing or pharmaceutical regulatory affairs including experience in filing documents to Regulatory agencies, and working directly with regulatory authorities

Knowledge, Skills, Abilities:

  • Core technical expertise expected in FDA, USDA, EU, and Asia Pacific regulations. Demonstrated knowledge in Food Safety Moderization (FSMA) laws, practices, and regulations affecting the Glanbia Nutritionals based businesses.

  • Demonstrates personal leadership and be an excellent mentor with a natural ability to bring divergent views together is highly desirable. Strong interpersonal and teamwork skills; ability to develop and maintain effective professional relations with colleagues and third party suppliers at all levels across the business.

  • Proven strong leadership skills ; ability and commitment for independent work with minimal supervision

Language, Computer & Numeracy:

  • Fluent in written and spoken English required

  • Computer skills and proficiency with SAP, Adobe, and Microsoft Office tools.

Personality, Characteristics:

  • Strategic thinker who can take an idea and turn it into action

  • Strong presence and ability to manage both up and down in the organization

  • Works with minimal supervision and remain productive at all times.

  • Operates well in a team environment and possess team-based problem solving skills.

  • Results focused and oriented toward accomplishment of team and organizational goals.

  • Stays positive and calm in difficult and/or trying circumstances.

  • Effectively handles multiple, rapidly changing and conflicting priorities and works well under pressure.

Travel requirements:

  • 20-30% Domestic and International

Typical Physical Activity

Physical Demands:

  • Regularly involves talking or listening, sitting, and the use of hands and fingers.

  • Regularly involves going up and down stairs.

  • Frequently involves reaching with hands and arms, standing and walking.

  • Occasionally involves crouching, stooping, kneeling and/or climbing or balancing.

Physical Requirements:

  • Must be able to lift and carry items weighing up to 25 pounds.

  • Manual dexterity sufficient to reach/handle items, works with the fingers, and perceives attributes of objects and materials.

  • Involves moderate physical activity performing non-strenuous daily activities of a primarily administrative nature.

Typical environmental conditions

  • May be exposed to moderate noise levels (i.e. office equipment, light traffic).

disclaimer

Must perform the essential duties and responsibilities with or without reasonable accommodation efficiently and accurately without causing significant safety threat to self or others. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.

Are you someone who likes to make it happen, make it better and make it fun? If so, our company offers you an excellent opportunity to do really interesting work and develop a career in a dynamic and innovative environment that is all about making you and our business successful.

Nearest Major Market: Chicago


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Director Of Regulatory Affairs

Glanbia PLC